JAK · Class II · 21 CFR 892.1750

FDA Product Code JAK: System, X-ray, Tomography, Computed

FDA product code JAK covers computed tomography (CT) systems.

These diagnostic imaging systems use rotating X-ray beams and computer processing to generate detailed cross-sectional and three-dimensional images of the body. CT is widely used in emergency medicine, oncology, cardiology, and surgical planning.

JAK devices are Class II medical devices, regulated under 21 CFR 892.1750 and reviewed by the FDA Radiology panel.

Leading manufacturers include Siemens Medical Solutions USA, Inc., Toshiba America Medical Systems, In.C and General Electric Co..

827
Total
827
Cleared
108d
Avg days
1976
Since
827 devices
289–312 of 827
Cleared Nov 24, 2015
SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope Power
K142955
Siemens Medical Solutions USA, Inc.
Radiology · 406d
Cleared Nov 20, 2015
IQQA Guide
K151414
Edda Technology
Radiology · 177d
Cleared Nov 12, 2015
SOMATOM Emotion 6/16
K151752
Siemens Medical Solutions USA, Inc.
Radiology · 136d
Cleared Nov 05, 2015
superDimension Navigation System
K151376
Covidien, LLC
Radiology · 167d
Cleared Nov 04, 2015
NeuViz 128 Multi-slice CT Scanner System
K151383
Neusoft Medical Systems Co., Ltd.
Radiology · 166d
Cleared Nov 02, 2015
syngo.CT Myocardial Perfusion
K150713
Siemens Medical Solutions USA, Inc.
Radiology · 228d
Cleared Oct 30, 2015
SCENARIA Phase 3 Whole-body X-ray CT System
K150595
Hitachi Medical Systems America, Inc.
Radiology · 235d
Cleared Oct 30, 2015
Lung Analysis Software
K151283
Vital Images, Inc.
Radiology · 169d
Cleared Oct 10, 2015
Vitrea CT Lung Density Analysis Software
K151919
Vital Images, Inc.
Radiology · 89d
Cleared Oct 09, 2015
Aquilion Lightning (TSX-035A/2, V7.0)
K151833
Toshibamedical Systems Corporation
Radiology · 95d
Cleared Oct 09, 2015
SOMATOM Definition Edge, SOMATOM Definition AS/AS+
K152036
Siemens Medical Solutions USA, Inc.
Radiology · 79d
Cleared Sep 30, 2015
Supria Whole-body X-ray CT System
K150565
Hitachi Medical Systems America, Inc.
Radiology · 208d
Cleared Aug 14, 2015
Low Dose CT Lung Cancer Screening Option for Qualified GE Systems
K151372
Ge Medical Systems, LLC
Radiology · 85d
Cleared Aug 13, 2015
Respiratory Gating for Scanners
K151533
Varian Medical Systems, Inc.
Radiology · 66d
Cleared Aug 11, 2015
syngo.CT Single Source Dual Energy
K150745
Siemens Medical Solutions USA, Inc.
Radiology · 141d
Cleared Aug 11, 2015
syngo.CT Dual Energy
K150757
Siemens Medical Solutions USA, Inc.
Radiology · 141d
Cleared Aug 07, 2015
Philips Spectral CT Applications
K150665
Philips Medical Systems Nethrlands BV
Radiology · 144d
Cleared May 18, 2015
syngo.CT Dental
K150785
Siemens Medical Solutions USA, Inc.
Radiology · 54d
Cleared May 15, 2015
Adaptive Motion Correction (AMC), CSMC-001A and 4D Airways
K143294
Toshibamedical Systems Corporation
Radiology · 179d
Cleared Apr 17, 2015
Vitrea CT Myocardial Perfusion
K150104
Vital Images, Inc.
Radiology · 87d
Cleared Apr 16, 2015
SOMATOM Definition Flash (VA48)
K143416
Siemens Medical Solutions USA, Inc.
Radiology · 139d
Cleared Apr 08, 2015
SOMATOM Definition AS/AS+
K143400
Siemens Medical Solutions USA, Inc.
Radiology · 131d
Cleared Apr 06, 2015
SOMATOM Definition Edge
K143401
Siemens Medical Solutions USA, Inc.
Radiology · 129d
Cleared Mar 26, 2015
SOMATOM Definition AS Open (VA48)
K143409
Siemens Medical Solutions USA, Inc.
Radiology · 118d